A pilot study of personalized biomarker-based treatment strategy or immunotherapy in patients with recurrent/metastatic squamous cell carcinoma of the head and neck UPSTREAM

European Organisation for Research and Treatment of Cancer0 sites340 target enrollmentSeptember 28, 2017

Overview

No summary available.

Registry

who.int

Start Date

September 28, 2017

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

European Organisation for Research and Treatment of Cancer

•1\- General inclusion criteria
•Histologically confirmed recurrent and/or metastatic SCCHN of the oral cavity, oropharynx, hypopharynx or larynx not amenable to curative treatment.
•Squamous cell carcinoma in cervical nodes with unknown primary are
•allowed if p16\-positive
•At least one measurable lesion by MRI or CT\-scan according to RECIST 1\.1, evaluated within 2 weeks prior to registration.
•Progressive disease after platinum\-based chemotherapy with or without cetuximab given as palliative treatment or progressive disease within 1 year if platinum\-based chemotherapy was given as a part of the multimodal curative treatment. Patients ineligible for platinum\-therapy
•and pre\-treated with anti\-PD1/PD\-L1 are allowed.
•ECOG performance status 0\-1 with a life expectancy of at least 12 weeks.
•Tumor core biopsy from any accessible tumor at the recurrent or metastatic site available for central testing.
•Adequate organ function, evaluated within 14 days prior to cohort allocation:

•1 \- General exclusion criteria
•Unresolved and significant toxicity CTCAE version 4\.03 grade \= 2 from previous anticancer therapy other than alopecia
•History of any of the cardiovascular conditions within 6 months prior to registration
•Nasopharynx and sino\-nasal tumor
•Surgery or investigational drugs or chemotherapy or other anticancer therapy within 3 weeks before cohort allocation
•Known untreated and uncontrolled brain metastases or leptomeningeal carcinomatosis
•Known diagnosis of immune deficiency or HIV
•Active Hepatitis B or C or pre\-existing liver cirrhosis
•History of Extensive disseminated/bilateral or known presence of IDL, but not history of prior radiation pneumonitis
•Other uncontrolled active illnesses or nonmalignant systemic disease